Last updated: 06/09/2025 10:10:43
Belimumab (BENLYSTA®) Pregnancy Registry
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: WEUKBRE6076: Belimumab (BENLYSTA) Pregnancy Registry Protocol
Trial description: This global Belimumab Pregnancy Registry will collect prospective data on pregnancies and pregnancy outcomes on a voluntary basis in women with systemic lupus erythematosus (SLE) who have received commercially supplied belimumab within the 4 months prior to and/or during pregnancy. The registry will also evaluate outcomes of infants born to mothers who were exposed to belimumab within the 4 months prior to and/or during pregnancy. This registry will add to the current clinical experience with belimumab and will complement reproductive data from animal toxicology studies. It will also assist clinicians in weighing the potential risks against the benefits of treatment for individual patients with SLE. GlaxoSmithKline (GSK) will sponsor the Belimumab Pregnancy Registry in countries where it holds Marketing Authorization.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Birth defects
Timeframe: Up to one year after birth
Secondary outcomes:
Other pregnancy outcomes
Timeframe: At birth
Infant outcomes
Timeframe: Up to 1 year after birth
Interventions:
Drug: belimumab
Enrollment:
77
Observational study model:
Cohort
Primary completion date:
2022-11-11
Time perspective:
Prospective
Clinical publications:
Patricia Juliao, Keele Wurst, Jeanne M Pimenta, Kim Gemzoe, Helain Landy, M Anthony Moody, Hugh Tilson, Deborah Covington, Tammy Moore, Rebecca Marino, Jennifer Gilbride, Andrew Liu, Paige Meizlik, Michelle Petri. Belimumab use during pregnancy: Interim results of the belimumab pregnancy registry. Birth Defects Res. 2022;
DOI: 10.1002/bdr2.2091
PMID: 36177676
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Pharmaceutical Product Development Clinical Research Organization (CRO)
Study date(s)
July 2012 to November 2022
Type
Observational
Phase
4
Participation criteria
Sex
Female
Age
Not applicable
Accepts healthy volunteers
No
- Pregnant women containing sufficient evidence to confirm that exposure to commercially supplied belimumab occurred within the 4 months prior to and/or during pregnancy
- Pregnant women with sufficient information to classify the pregnancy as prospective or retrospective (ie,whether the outcome of pregnancy was known at the time of first contact with the registry)
- Reported cases that do not meet the minimum inclusion criteria for registry enrollment will be ineligible for inclusion in the registry
Inclusion and exclusion criteria
Inclusion criteria:
- Pregnant women containing sufficient evidence to confirm that exposure to commercially supplied belimumab occurred within the 4 months prior to and/or during pregnancy
- Pregnant women with sufficient information to classify the pregnancy as prospective or retrospective (ie,whether the outcome of pregnancy was known at the time of first contact with the registry)
- Pregnant women with full contact information to allow for follow-up (name, address, telephone number/email address) and contact information for applicable HCPs if initial reporter is the pregnant woman
- Consent provided by the pregnant woman for her participation and assent for participation of her infant.
Exclusion criteria:
- Reported cases that do not meet the minimum inclusion criteria for registry enrollment will be ineligible for inclusion in the registry
Trial location(s)
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2022-11-11
Actual study completion date
2022-11-11
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Participate in clinical trial
Additional information
Belimumab pregnancy registry/GlaxoSmithKline pregnancy registries
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